Breast cancer survivor testified at FDA

Grateful that a breast examination as part of a study of an automated ultrasound device led to her cancer diagnosis, Yvette Kaweblum testified at a Food and Drug Administration hearing in Washington, D.C. in April. The device was approved by the FDA last month.

"I was very lucky that I was part of the research," Kaweblum, 55, of Boca Raton said as she recounted how the two-year study of the Soma-V device at Boca Raton Regional Hospital's Center for Breast Care showed three lesions that regular mammography failed to detect.

The diagnosis was a shock said Kaweblum who went on to have a double mastectomy, breast reconstruction and chemotherapy. But she is glad to be alive. "I am very thankful to God," Kaweblum said.

In a letter to the FDA in which she asked to tell her story at the hearing, Kaweblum wrote, "I owe my life to the ABUS [Automated Breast Ultrasound]."

Rabbi Efrem Goldberg of Boca Raton Synagogue sent a letter to the FDA asking that Kaweblum be allowed to testify in favor of the device. "Her quest now," Goldberg wrote, "is to lobby for the ultrasound machine that will help to detect breast cancer in Ashkenazi women with dense breast tissue."

The standard mammogram is not as accurate for women with dense breasts, said Dr. Juliette The, a radiologist at Boca Raton Regional Hospital's Center for Breast Care. About 40 percent of women have dense breasts, The said, adding that these women have a four to six times higher rate of breast cancer.

It is difficult to see lesions in women with dense breasts, which are composed of fat or dense granular tissue, The said. The breast shows up as white and the cancers also are white, she said. Ultrasounds, The said, can show potential masses or cysts, which show up as dark lesions.

Automated breast ultrasound is quite different from tomosynthesis or three dimensional x-ray of the breast, which has been getting attention in the press recently.